Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
Initial treatment of clinically relevant vitamin D deficiency in adults.
The dosage must be determined individually by the treating doctor depending on the extent of the necessary vitamin D supplementation. The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), severity of the disease and patients response to treatment.
Recommended dose: 25.000 IU every week.
After first month, lower doses may be considered.
Following this initial treatment, maintenance therapy may be required with a dose determined individually by the treating doctor.
Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed.
THORENS must not be used in patients with severe renal impairment.
No posology adjustment is required in patients with hepatic impairment.
THORENS 25.000 IU capsules is not recommended in children and adolescents under 18 years of age.
THORENS 25.000 IU capsules is not recommended.
The capsules should be swallowed whole.
Patients should be advised to take THORENS preferably with a meal (see section 5.2 Pharmacokinetic properties - “Absorption”).
Discontinue THORENS when calcaemia exceeds 10.6 mg/dl (2.65 mmol/l) or if the calciuria exceeds 300 mg/24 hours in adults or 4-6 mg/kg/day in children. An overdose manifests as hypercalcaemia and hypercalciuria, the symptoms of which include the following: nausea, vomiting, thirst, constipation, polyuria, polydipsia and dehydration.
Chronic overdosage may lead to vascular and organ calcification, as a result of hypercalcaemia.
Discontinue administration of THORENS and initiate rehydration.
2 years.
Do not store above 30°C.
Do not freeze.
Store in the original package in order to protect from light.
The immediate container is an Aluminium-PVC/PVDC blisters in cardboard boxes.
Packs of 3 capsules (1 blister/box), 4 capsules (1 blister/box), 8 capsules (2 blisters/box) and 12 capsules (3 blisters/box).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with the local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
